Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00177164 · ClinicalTrials.gov registry record · Phase 3
Risperdal Consta for Bipolar Disorder
A Phase 3 study, sponsored by University of Pittsburgh.
- Completed
- Registry status
- Phase 3
- Development phase
- 50
- Enrollment target
NCT00177164 is a Phase 3 study that has completed, run by University of Pittsburgh. The registered enrollment target is 50 participants.
The verdict
NCT00177164, a Phase 3 study, has completed, sponsored by University of Pittsburgh.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 50 participants
- Enrollment target
Study Summary
We recruited 50 consenting adult subjects with DSM-IV TR diagnoses of bipolar disorder who were about to initiate or switch their current antipsychotic agent. Only 48 patients (23 in the risperidone LAI group and 25 in the oral AAP group) contributed data to the assessments. Patients were titrated and cross-tapered during a 3 month titration and stabilization phase. They were followed for an additional 12 months. Clinical outcomes such as study drop out, adverse events, worsening of symptoms, crisis interventions, need for additional medication, hospitalizations etc. were evaluated from months 3 to 15. The numbers of clinical events (pooled) will be used to evaluate if the long acting injectable form of risperidone has an advantage over the oral second generation antipsychotic agents in terms of treatment continuity and clinical stability.
Interventions
- DRUG Injectable Risperidone (Consta) or oral antipsychotic
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2003-11 |
| Est. Completion | 2009-12 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00177164
The ClinicalTrials.gov registry entry for NCT00177164 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Pittsburgh, which has 1,238 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Injectable Risperidone (Consta) or oral antipsychotic is the first listed.
NCT00177164 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00177164 about?
NCT00177164 is a clinical study titled "Risperdal Consta for Bipolar Disorder". We recruited 50 consenting adult subjects with DSM-IV TR diagnoses of bipolar disorder who were about to initiate or switch their current antipsychotic agent. Only 48 patients (23 in the risperidone LAI group and 25 in the oral AAP group) contributed data to the assessments. Patients were titrated a...
What is the current status of trial NCT00177164?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 50 participants. The study started on 2003-11. Estimated completion is 2009-12.
What interventions are being tested in trial NCT00177164?
The interventions under investigation include: Injectable Risperidone (Consta) or oral antipsychotic (DRUG).
Who is sponsoring clinical trial NCT00177164?
This trial is sponsored by University of Pittsburgh, which has 1,238 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.